Fluid delivery device, transcutaneous access tool and insertion mechanism for use therewith

ABSTRACT

A fluid delivery device comprising a fluid reservoir; a transcutaneous access tool fluidly coupled to the fluid reservoir, the transcutaneous access tool including a needle or a trocar; and a transcutaneous access tool insertion mechanism for deploying the transcutaneous access tool, wherein the insertion mechanism is configured to insert and retract the needle/trocar in a single, uninterrupted motion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of PCT Application Serial No.PCT/US13/34674 filed Mar. 29, 2013 and claims the benefit of U.S.Provisional Application Ser. No. 61/618,028, filed Mar. 30, 2012, theteachings of which are incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to fluid delivery devices for deliveringtherapeutic liquids to a patient, and more particularly, to an infusionpump for delivering therapeutic liquids to a patient.

BACKGROUND INFORMATION

Fluid delivery devices have numerous uses such as delivering a liquidmedicine or other therapeutic fluid to a patient subcutaneously. In apatient with diabetes mellitus, for example, ambulatory infusion pumpshave been used to deliver insulin to a patient. These ambulatoryinfusion pumps have the ability to offer sophisticated fluid deliveryprofiles including variable basal rates and bolus requirements. Theability to carefully control drug delivery can result in better efficacyof the drug and therapy and less toxicity to the patient.

Some existing ambulatory infusion pumps include a reservoir to containthe liquid medicine and use electromechanical pumping or meteringtechnology to deliver the liquid medicine via tubing to a needle and/orsoft cannula that is inserted subcutaneously into the patient. Theseexisting devices allow control and programming via electromechanicalbuttons or switches located on the housing of the device. The devicesinclude visual feedback via text or graphic screens and may includealert or warning lights and audio or vibration signals and alarms. Suchdevices are typically worn in a harness or pocket or strapped to thebody of the patient.

Some infusion pumps have been designed to be relatively small, low cost,light-weight, and easy-to-use. One example of such a pump is theOMNIPOD® insulin infusion pump available from Insulet Corporation.Examples of infusion pumps are also described in greater detail, forexample, in U.S. Pat. Nos. 7,128,727; 7,018,360; and 7,144,384 and U.S.Patent Application Publication Nos. 2007/0118405, 2006/0282290,2005/0238507, and 2004/0010207, which are fully incorporated herein byreference. These pumps include insertion mechanisms for causing atranscutaneous access tool, such as a needle and/or soft cannula, to beinserted into a patient. Although such pumps are effective and providesignificant advantages over other insulin infusion pumps, the design ofthe insertion mechanism may be improved, for example, to reduce the sizeof the pump, to improve the comfort to the user, and/or to incorporatecontinuous glucose monitoring (CGM). These pumps also include fluiddriving mechanisms for driving fluid from a reservoir through thetranscutaneous access tool. The fluid driving mechanisms may also beimproved to facilitate assembly and use of the pump.

SUMMARY

The present disclosure provides various fluid delivery devices todeliver a liquid medicine or other therapeutic fluid to a patientsubcutaneously. In certain embodiments the fluid delivery device maycomprise an ambulatory insulin infusion device to administer insulin toa patient. The fluid delivery device may include one or more batteriesfor providing a power source, a fluid reservoir for holding a fluid, afluid drive mechanism for driving the fluid out of the reservoir, afluid passage mechanism for receiving the fluid from the reservoir andpassing the fluid to a destination via a transcutaneous access tool, anda transcutaneous access tool insertion mechanism for deploying thetranscutaneous access tool.

In certain embodiments, the transcutaneous access tool includes aneedle/trocar, and the transcutaneous access tool insertion mechanism isconfigured to insert and retract the needle/trocar in a single,uninterrupted motion. In such a manner, the pain of insertion andretraction of the needle/trocar experienced by the patient may bereduced.

In certain embodiments, the fluid delivery device may comprise a fluidreservoir; a transcutaneous access tool fluidly coupled to the fluidreservoir, the transcutaneous access tool including a needle/trocar; anda transcutaneous access tool insertion mechanism for deploying thetranscutaneous access tool, wherein the insertion mechanism isconfigured to insert and retract the needle/trocar in a single,uninterrupted motion.

In certain embodiments, the fluid delivery device may comprise a fluidreservoir; a transcutaneous access tool fluidly coupled to the fluidreservoir, the transcutaneous access tool including at least aneedle/trocar; and a transcutaneous access tool insertion mechanism fordeploying the transcutaneous access tool, wherein the insertionmechanism is configured to insert the needle/trocar with an increasinginsertion force as the needle/trocar moves in an insertion direction.

In certain embodiments, the transcutaneous access tool insertionmechanism for deploying a transcutaneous access tool including a cannulaand a needle/trocar located inside of the cannula may comprise a firstsliding member configured to move the needle/trocar in an insertiondirection and a retraction direction; a second sliding member configuredto move the cannula in the insertion direction; a torsion spring; andlinkages coupled between the torsion spring and the first sliding membersuch that energy stored in the torsion spring causes the linkages tomove the first sliding member in the insertion direction and theretraction direction.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages will be better understood byreading the following detailed description, taken together with thedrawings wherein:

FIG. 1 is a top perspective view of a fluid delivery device with atranscutaneous access tool insertion mechanism in a pre-deploymentposition, consistent with the present disclosure;

FIG. 2 is a bottom perspective view of a needle and cannula retractedinto the fluid delivery device in the pre-deployment position shown inFIG. 1;

FIG. 3 is a top perspective view of the fluid delivery device shown inFIG. 1 with the insertion mechanism in an intermediate position;

FIG. 4 is a bottom perspective view of the needle and cannula extendingfrom the fluid delivery device in the intermediate position shown inFIG. 3;

FIG. 5 is a top perspective view of the fluid delivery device shown inFIG. 1 with the insertion mechanism in a post-deployment position;

FIG. 6 is a bottom perspective view of the cannula extending from thefluid delivery device in the post-deployment position shown in FIG. 5;

FIG. 7 is a side perspective view of another embodiment of the insertionmechanism, consistent with the present disclosure, in a pre-deploymentposition;

FIG. 8 is a side perspective view of the insertion mechanism shown inFIG. 7 in an intermediate position;

FIG. 9 is a side perspective view of the insertion mechanism shown inFIG. 7 in a post-deployment position; and

FIG. 10 is a top perspective view of the second sliding member of theinsertion mechanism shown in FIG. 7 locked in the pre-deployment andpost-deployment positions.

DETAILED DESCRIPTION

A fluid delivery device, consistent with embodiments of the presentdisclosure, may be used to deliver a therapeutic fluid (e.g. a liquidmedicine) to a patient via a transcutaneous access tool, such as aneedle/trocar and/or a cannula. A transcutaneous access tool insertionmechanism may be used to deploy the transcutaneous access tool, forexample, by inserting and retracting a needle/trocar in a single,uninterrupted motion. The insertion mechanism may also provide anincreasing insertion force as the needle/trocar moves in the insertiondirection. The fluid delivery device may also include a clutch mechanismto facilitate filling a reservoir and engagement of a drive mechanismfor driving fluid out of the reservoir. In certain embodiments, thefluid delivery device may comprise an ambulatory insulin infusiondevice.

In other embodiments, a fluid delivery device may be used to deliver atherapeutic fluid to a patient with integrated monitoring, such ascontinuous glucose monitoring (CGM). In these embodiments, the fluiddeliver device may include a transcutaneous access tool configured tointroduce a monitoring test strip through the skin of the patient, forexample, using one or more needles, cannulas and/or trocars.

Referring to FIGS. 1-6, one embodiment of a fluid delivery device 100 isshown and described. In the exemplary embodiment, the fluid deliverydevice 100 is used to subcutaneously deliver a fluid, such as a liquidmedicine (e.g. insulin), to a person or an animal. Those skilled in theart will recognize that the fluid delivery device 100 may be used todeliver other types of fluids. The fluid delivery device 100 may be usedto deliver fluids in a controlled manner, for example, according tofluid delivery profiles accomplishing bolus requirements, continuousinfusion and variable flow rate delivery.

According to one embodiment, the fluid delivery device 100 may includeone or more batteries 110 for providing a power source, a fluidreservoir 130 for holding a fluid, a fluid drive mechanism 150 fordriving the fluid out of the reservoir 130, a fluid passage mechanism170 for receiving the fluid from the reservoir 130 and passing the fluidto a destination via a transcutaneous access tool 172, and atranscutaneous access tool insertion mechanism 180 for deploying thetranscutaneous access tool 172. The fluid delivery device 100 mayinclude a circuit board 101 with control circuitry for controlling thedevice and a chassis 102 that provides mechanical and/or electricalconnections between components of the fluid deliver device 100. Thefluid delivery device 100 may also include a housing 104 to enclose thecircuit board 101, the chassis 102, and the components 110, 130, 150,170, 180.

The fluid delivery device 100 may also include integrated monitoringsuch as continuous glucose monitoring (CGM). A monitor test strip 120coupled to a monitor (not shown) in the device 100 may be introduced bythe transcutaneous access tool 172 subcutaneously. One example of themonitor test strip is a CGM test strip (such as the type available fromNova Biomedical) which may be understood as a glucose sensor configuredto test for a concentration level of glucose in the blood of a patient.The fluid delivery device 100 may be configured to receive data from themonitoring test strip concerning a glucose level of the patient, anddetermining an output of insulin from the reservoir based on the glucoselevel.

The transcutaneous access tool 172 includes an introducer trocar orneedle 174 at least partially positioned within a lumen 175 of a cannula176 (e.g., a soft flexible cannula), which is capable of passing thefluid into the patient. In particular, the introducer needle/trocar 174may initially penetrate the skin such that both the introducerneedle/trocar 174 and the cannula 176 are introduced (inserted) into thepatient, and the introducer needle/trocar 174 may then be retractedwithin the cannula 176 such that the cannula 176 remains inserted. Afluid path, such as tubing 178, fluidly couples the reservoir 130 to thelumen 175 of cannula 176 of the transcutaneous access tool 172.

The transcutaneous access tool insertion mechanism 180 is coupled to thetranscutaneous access tool 172 to deploy the transcutaneous access tool172, for example, by inserting the needle/trocar 174 and cannula 176through the skin of a patient and retracting the needle/trocar 174. Inthe illustrated embodiment, the insertion mechanism 180 includes aspring-biased linkage mechanism 182 and sliding members 184, 186 coupledto the needle/trocar 174 and cannula 176, respectively, for moving theneedle/trocar 174 and cannula 176 in the insertion direction and formoving the needle/trocar 174 in the retraction direction. In a single,uninterrupted motion, the spring-biased linkage mechanism 182 moves froma pre-deployment position (FIG. 1) with both needle/trocar 174 andcannula 176 retracted (FIG. 2) to an intermediate position (FIG. 3) withboth needle/trocar 174 and cannula 176 inserted (FIG. 4) to apost-deployment position (FIG. 5) with the needle/trocar 174 retractedand the cannula 176 inserted (FIG. 6).

One embodiment of the spring-biased linkage mechanism 182 includes ahelical torsion spring 181 and first and second linkages 183 a, 183 bcoupled between the torsion spring 181 and the first sliding member 184.Energy stored in the torsion spring 181 applies a force to the linkages183 a, 183 b, which applies a force to the first sliding member 184 tomove the first sliding member 184 in both the insertion direction and inthe retraction direction. In the pre-deployment position (FIG. 1), thetorsion spring 181 is loaded and the sliding members 184, 186 are lockedand prevented from moving. When the sliding members 184, 186 arereleased, the energy stored in the torsion spring 181 causes the firstlinkage 183 a to rotate (e.g., clockwise as shown), which applies aforce to the first sliding member 184 through the second linkage 183 bcausing the first sliding member 184 with the needle/trocar 174 to move(with the second sliding member 186) in the insertion direction. In theintermediate position (FIG. 3), the linkages 183 a, 183 b are fullyextended with the needle/trocar 174 and cannula 176 being inserted, thesecond sliding member 186 is locked, and the remaining energy stored inthe torsion spring 181 causes the first linkage 183 a to continue torotate, which applies an opposite force to the first sliding member 184through the second linkage 183 b causing the first sliding member 184with the needle/trocar 174 to move in the retraction direction to thepost-deployment position (FIG. 5). In the illustrated embodiment, thesecond sliding member 186 is locked against retraction by one or morelatches 187. Thus, in the foregoing manner, the continuous uninterruptedclockwise rotation of first linkage 183 a via the energy of torsionspring 181 provides the transcutaneous access tool insertion mechanism180 with the ability to insert and retract the needle/trocar 174 in asingle, uninterrupted motion.

The spring-biased linkage mechanism 182 allows a single spring andmotion to achieve both the insertion and retraction and has a relativelysmall size. The spring-biased linkage mechanism 182 also reduces thestatic stresses caused by locking and holding back the sliding members184, 186 and provides a smoother and more comfortable needle/trocarinsertion because of the way the linkages 183 a, 183 b vector the forcesapplied to the sliding members 184, 186. The static forces on thesliding members 184, 186 are relatively small in the pre-deploymentposition when the linkages 183 a, 183 b are fully retracted. When thedeployment starts and the linkages 183 a, 183 b start to becomeextended, the insertion forces increase because the force vectorsincrease in the insertion direction as the linkages extend 183 a, 183 buntil a maximum insertion force is reached at the fully extended,intermediate position. By gradually increasing the insertion forces, theneedle/trocar insertion and retraction is smoother, quieter and lesspainful.

Another embodiment of an insertion mechanism 280 is shown in greaterdetail in FIGS. 7-10. The sliding members 284, 286 are slidably receivedin a frame 290 and moved by a spring-biased linkage mechanism 282including torsion spring 281 and linkages 283 a, 283 b. In thisembodiment, a cam finger 292 (e.g., extending from the frame 290)engages beneath one or both of the sliding members 284, 286 to lock thesliding members in the retracted or pre-deployment position (FIG. 7). Inthis pre-deployment position, the cam finger 292 is held against thesliding members 284, 286 by a release bar 296, which may be moved(rotated) to allow the cam finger 292 to move and release the slidingmembers 284, 286 (FIG. 8). The cam finger 292 may be biased in adownward direction and/or the second sliding member 286 may include acam surface 287 to help facilitate movement along the cam finger 292over locking mechanism 293 upon actuation.

The release bar 296 includes a lever 297 for pivoting the release bar296 between an engaged position against the cam finger 292 (FIG. 7) anda disengaged position releasing the cam finger 292 (FIG. 8). The releasebar 296 may be biased toward the disengaged position and held againstthe cam finger 292 in the engaged position until the lever 297 isreleased allowing the release bar 296 to move to the disengagedposition. In the illustrated embodiment, the lever 297 engages arotating surface 257 of a drive wheel 256 of the fluid drive mechanism150 such that the lever 297 is held in the engaged position for part ofthe rotation and is released at a certain point during the rotation(e.g., when a flat portion of the rotating surface 257 allows the lever297 to move).

As shown in FIGS. 9 and 10, the cam finger 292 may also be used to lockthe second sliding member 286 in the insertion position. A lockingportion 288 of the second sliding member 286 engages a locking portion293 of the cam finger 292 when the linkage mechanism 282 is fullyextended in the intermediate position and prevents the second slidingmember 286 from retracting such that the cannula remains inserted. Asdiscussed above, the second sliding member 286 may also be locked by oneor more latches 187 (shown in FIGS. 1-6) extending from a top of theframe 290.

While the principles of the invention have been described herein, it isto be understood by those skilled in the art that this description ismade only by way of example and not as a limitation as to the scope ofthe invention. Other embodiments are contemplated within the scope ofthe present invention in addition to the exemplary embodiments shown anddescribed herein. Modifications and substitutions by one of ordinaryskill in the art are considered to be within the scope of the presentinvention, which is not to be limited except by the following claims.

What is claimed is:
 1. A fluid delivery device comprising: a fluidreservoir; a transcutaneous access tool fluidly coupled to the fluidreservoir, the transcutaneous access tool including a needle or atrocar; and a transcutaneous access tool insertion and retractionmechanism, wherein the insertion and retraction mechanism is configuredto drive insertion and retraction of the needle/trocar with a driveforce which rotates around an axis, such that the drive force providesan insertion force which inserts the needle/trocar during a firstportion of the rotation around the axis and the drive force provides aretraction force to retract the needle/trocar during a second portion ofthe rotation around the axis.
 2. The fluid delivery device of claim 1wherein the insertion and retraction mechanism is configured to increasean insertion force as the needle/trocar moves in an insertion direction.3. The fluid delivery device of claim 1 wherein the transcutaneousaccess tool includes a cannula, and wherein the needle/trocar is locatedwithin the cannula such that the cannula remains inserted when theneedle/trocar is retracted.
 4. The fluid delivery device of claim 3wherein the insertion and retraction mechanism comprises: a firstsliding member configured to move the needle/trocar in an insertiondirection and in a retraction direction; a second sliding memberconfigured to move the cannula in the insertion direction; a torsionspring; and linkages coupled between the torsion spring and the firstsliding member such that energy stored in the torsion spring causes thelinkages to move the first sliding member in the insertion direction andthe retraction direction.
 5. The fluid delivery device of claim 4wherein the insertion and retraction mechanism further comprises: aframe slidably receiving the sliding members and configured to lock thesliding members in a pre-deployment position and to lock the secondsliding member in a post-deployment position.
 6. The fluid deliverydevice of claim 5 wherein the frame includes a cam finger configured tolock the sliding members in the pre-deployment position.
 7. The fluiddelivery device of claim 6 wherein the cam finger is configured to lockthe second sliding member in the post-deployment position.
 8. The fluiddelivery device of claim 6 wherein the insertion and retractionmechanism further comprises: a release bar configured to hold the camfinger when the cam finger locks the sliding members in thepre-deployment position and configured to release the cam finger toallow the sliding members to move in the insertion direction.
 9. Thefluid delivery device of claim 8 further comprising a drive mechanismfor driving fluid from the reservoir, wherein the drive mechanismengages the release bar and triggers movement of the release bar torelease the cam finger.
 10. A fluid delivery device comprising: a fluidreservoir; a transcutaneous access tool fluidly coupled to the fluidreservoir, the transcutaneous access tool including a cannula, and aneedle or a trocar located inside the cannula; a transcutaneous accesstool insertion and retraction mechanism configured to deploy thetranscutaneous access tool, comprising a first sliding member coupledwith the needle/trocar and operable to move the needle/trocar in aninsertion direction and in a retraction direction; a second slidingmember coupled with the cannula and operable to move the cannula in theinsertion direction; a torsion spring; linkages coupled between thetorsion spring and the first sliding member such that energy stored inthe torsion spring causes the linkages to move the first sliding memberin the insertion direction and the retraction direction; and wherein thetorsion spring has a longitudinal axis and the linkages rotate aroundthe longitudinal axis of the torsion spring.
 11. The fluid deliverydevice of claim 10 wherein the transcutaneous access tool insertion andretraction mechanism is configured to insert the needle/trocar with anincreasing insertion force as the needle/trocar moves in an insertiondirection; and wherein the torsion spring operates to increase theinsertion force as the needle/trocar moves in the insertion direction.12. The fluid delivery device of claim 10 wherein the needle/trocar islocated within the cannula such that the cannula remains inserted whenthe needle/trocar is retracted.
 13. (canceled)
 14. The fluid deliverydevice of claim 10 wherein the insertion and retraction mechanismfurther comprises: a frame slidably receiving the sliding members andconfigured to lock the sliding members in a pre-deployment position andto lock the second sliding member in a post-deployment position.
 15. Thefluid delivery device of claim 14 wherein the frame includes a camfinger configured to lock the sliding members in the pre-deploymentposition.
 16. The fluid delivery device of claim 15 wherein the camfinger is configured to lock the second sliding member in thepost-deployment position.
 17. The fluid delivery device of claim 15wherein the insertion and retraction mechanism further comprises: arelease bar configured to hold the cam finger when the cam finger locksthe sliding members in the pre-deployment position and configured torelease the cam finger to allow the sliding members to move in theinsertion direction.
 18. The fluid delivery device of claim 17 furthercomprising a drive mechanism for driving fluid from the reservoir,wherein the drive mechanism engages the release bar and triggersmovement of the release bar to release the cam finger.
 19. Atranscutaneous access tool insertion and retraction mechanism configuredto deploy a transcutaneous access tool including a cannula and a needleor a trocar located inside of the cannula, the insertion and retractionmechanism comprising: a first sliding member coupled with theneedle/trocar and operable to move the needle/trocar in an insertiondirection and in a retraction direction; a second sliding member coupledwith the cannula and operable to move the cannula in the insertiondirection; a torsion spring having a longitudinal axis; first and secondlinkages coupled between the torsion spring and the first sliding membersuch that, upon deployment, energy stored in the torsion spring causesthe first and second linkages to cooperate to move the first slidingmember in the insertion direction and the retraction direction; andwherein, upon deployment, the first linkage is arranged to rotate aboutthe longitudinal axis of the torsion spring, and the first linkage andsecond linkage are arranged to rotate relative to each other about amoving pivot to move the first sliding member in the insertion directionand the retraction direction.
 20. The transcutaneous access toolinsertion and retraction mechanism of claim 19 further comprising: aframe slidably receiving the sliding members and configured to lock thesliding members in a pre-deployment position and to lock the secondsliding member in a post-deployment position.
 21. The transcutaneousaccess tool insertion and retraction mechanism of claim 20 wherein theframe includes a cam finger configured to lock the sliding members inthe pre-deployment position.
 22. The transcutaneous access toolinsertion and retraction mechanism of claim 21 wherein the cam finger isconfigured to lock the sliding members in the post-deployment position.23. The transcutaneous access tool insertion and retraction mechanism ofclaim 21 further comprising: a release bar configured to hold the camfinger when the cam finger locks the sliding members in thepre-deployment position and configured to release the cam finger toallow the sliding members to move in the insertion direction.